Kornimate/medical-research-clean huggingface dataset:
intravenous immunoglobulins in severe and refractory solar urticaria

Conditions: Solar Urticaria

Summary: solar urticaria is a rare but debilitating disease that can severely impact the quality of life, restricting outdoor activities.treatment, based on sun protection and anti-histaminic drugs, is efficacious in 2 patients out of 3. in refractory patients, photodesensitization or immunosuppressive treatments such as cyclosporin a can be proposed. as in idiopathic urticaria, intravenous immunoglobulins (ivig)have been shown, in a retrospective study of 7 patients, to dramatically improve 71% of patients. in an open-label prospective multicenter study, we aim to demonstrate the efficacy of a single ivig administration (2g/kg) in 10 patients affected with severe and refractory solar urticaria.


Eligibility criteria:
inclusion criteria: * social insurance * signed informed consent * solar urticaria (su) confirmed with photoexplorations * su involving the face or generalized to the whole body or accompanied with bronchospasm or triggered by artificial light or per annual su * su with altered quality of life * su resistant to photoprotection * su resistant to the association of two different antihistaminics during 3 months exclusion criteria: * pregnancy * heat triggered urticaria * contra-indications to ivig

Keywords: intravenous immunoglobulins solar urticaria minimal urticaria dose quality of life safety
home-based transcranial direct current stimulation (tdcs) to promote social communication and behaviour in children with autism spectrum disorder (asd)

Conditions: Autism Spectrum Disorder

Summary: transcranial direct current stimulation (tdcs) is a form of non-invasive brain stimulation that can be delivered in a home setting. it is a safe and tolerable intervention that has shown promise for improving positive social communication and self-regulation in youth with autism spectrum disorder (asd). children and youth with asd will be randomized to at-home tdcs or sham control stimulation for 3 weeks. we will measure the effect of at-home tdcs on the brain mechanisms and clinical measures of social communication and self-regulation..

transcranial direct current stimulation (tdcs) is a form of non-invasive brain stimulation that can be delivered in a home setting. it is a safe and tolerable intervention that has shown promise for improving positive social communication and self-regulation in youth with autism spectrum disorder (asd). previous studies have been limited by small and poorly represented samples, lack of experimental control, insufficient follow-up periods, inadequate blinding and the absence of neural outcome measures. our project will collect pilot data on the effects of home-based tdcs on reducing disruptive behaviours in youth with asd, in order to inform the design of a follow-up full-scale clinical trial. we will recruit youth with asd who experience clinically significant difficulties with social communication and self-regulation. participants will be randomized to tdcs or sham control stimulation for 3 weeks. we will measure the effect of tdcs on the brain mechanisms and clinical measures of social communication and self-regulation..

Eligibility criteria:
inclusion criteria: * children with a diagnosis of autism spectrum disorder and self-regulation impairment or social communication challenges * able to participate in tdcs exclusion criteria: * children with contraindications to tdcs (history of seizures, family history of seizures, metal implants) * co-existing neurological conditions (epilepsy, stroke, etc.)

Keywords: tdcs mri brain stimulation
thoracic paravertebral block for postoperative pain management after vats

Conditions: Pain, Postoperative

Summary: this randomized controlled trial evaluated the efficacy of a thoracic paravertebral block (tpvb) in reducing opioid requirements and pain intensity in the pacu after video-assisted thoracoscopic surgery (vats).

this randomized controlled trial evaluated the efficacy of a thoracic paravertebral block (tpvb) in reducing opioid requirements and pain intensity in the pacu after video-assisted thoracoscopic surgery (vats). adult patients scheduled for elective vats who meet the eligibility criteria will be randomized to either arm: arm 1: general anesthesia with tpvb; arm 2: general anesthesia alone (control group). primary outcome: to assess opioid requirement in the pacu

Eligibility criteria:
inclusion criteria: * adult patients scheduled for elective vats, asa physical status ii-iii, bmi 19-40. exclusion criteria: * patient refusal, coagulation disorders, contraindications to tpvb, chronic analgesic use, mental illness

Keywords: opioids, pain management, thoracic paravertebral block. vats regional anesthesia
telemetric arrhythmia diagnosis in adults

Conditions: Atrial Fibrillation; Arrhythmia

Summary: the purpose of this study is to assess efficacy of prolonged full disclosure electrocardiogram (ecg) monitoring and signal analysis using advanced telemetric technology in comparison with a standard holter ecg recording and an event holter recording to diagnose cardiac arrhythmia.

irregular and/or rapid beating of the heart called heart palpitations can occur in individuals without heart disease and the reasons for their palpitations are unknown. together with heart palpitations silent arrhythmia may be present that could lead to serious complications (eg. stroke). in others, palpitations result from heart rhythm disturbances, sometimes life threatening. standard diagnostic methods such as 24 hours holter ecg monitoring or event holter do not guarantee early diagnosis of the arrhythmia. prolonged heart rhythm recording and analysis using an automatic full disclosure telemetric device increase probability of arrhythmia diagnosis and early administration of applicable treatment. study patients will be diagnosed using standard holter ecg monitoring and 14 days telemetric full disclosure ecg monitoring. the full disclosure signal will be subsequently analyzed in the event monitoring mode by an independent consultant. efficacy of telemetric monitoring in diagnosis of cardiac arrhythmia will be assessed in comparison with the standard holter monitoring and event monitoring.

Eligibility criteria:
inclusion criteria: * age - between 18 and 80 years old * history of symptoms potentially caused by arrhythmia * symptoms occuring at least monthly * patient informed consent * declarative and feasible compliance (patient understands basic instructions regarding device use) exclusion criteria: * evidence of previously recorded arrhythmia * inability to comply with the study protocol * lack of patient cooperation

Keywords: atrial fibrillation cardiac arrhythmia ecg telemonitoring telemetry holter
steriwave icu pilot study

Conditions: Ventilator Acquired Pneumonia; Hospital Acquired Pneumonia; Hospital Acquired Infections; Nasal Decolonization of Staphylococcus Aureus

Summary: this is a single-center, non-blinded, prospective, pilot study enrolling patients admitted to the critical care unit at royal columbian hospital. this study investigates the effects of universal nasal decolonization using antimicrobial photodynamic therapy (apdt) on the prevention of hospital-acquired pneumonia (hap), ventilator-acquired pneumonia (vap), and hospital-acquired bloodstream infection (bsi) in this patient population. main objectives include: * to determine whether a large, multi-center rct of this protocol is feasible * to determine baseline rates of vap, hap, and icu-acquired bsi * to gather preliminary efficacy data regarding vap, hap, and icu-acquired bsi prevention using universal apdt nasal decolonization * to gather preliminary microbiological data on the effect of universal apdt procedures on nasal carriage of various microoganisms in icu patients.


Eligibility criteria:
inclusion criteria: * all icu patients 19 years and above * expected length of icu stay \>48 hrs exclusion criteria: * pregnant/breastfeeding individuals * allergy to methylene blue and/or chlorhexidine gluconate, or unknown allergy status * nasal or facial trauma that limits access to the nose * inability for the patients to tolerate or comply with treatment, as determined by their treating physician * patient, tsdm or mrp declines participation * co-enrolment with other research studies will be considered in an individual basis.
percutaneous irreversible electroportion for unresectable breast cancer

Conditions: Breast Cancer

Summary: this trial is studying how well irreversible electroportion (ire) therapy works in treating patients with breast cancer. ire kills tumor cells by electrical impulses creating nano-pore on the cell membrane and inducing target cell death.this may be an effective treatment for patients with unresectable breast cancer.

this is a phase i/ii non-randomized exploratory study. all fully eligible and registered patients will undergo imaging by mammography, ultrasound, and breast mri. the primary and secondary objectives of the study are described below. objectives primary treatment efficacy as measured by modified response evaluation criteria in solid tumors (recist) criteria by computed tomography (ct) or magnetic resonance (mr) imaging. secondary safety using common terminology criteria for adverse events (ctcae) version 3.0 criteria. to describe the adverse events associated with ire to prospectively gather pain assessment data on cryoablation and surgical resection explore technical variables that may affect the success of ire

Eligibility criteria:
inclusion criteria: 1. women 18 years or older with unresectable breast cancer, not amenable/willing to adenomammectomy. 2. breast carcinoma diagnosed by core needle biopsy. 3. any menopausal status. 4. no history of en bloc open surgical biopsy and/or lumpectomy for diagnostic/treatment of the index breast cancer. 5. tumor size ≤ 5.0 cm in greatest diameter. largest size measured by required scans (mammogram, ultrasound and mri) will be used to determine eligibility. 6. tumor enhancement on pre-study mri. 7. tumor with \< 25% intraductal components in the aggregate. 8. progressed within 12 months from prior adjuvant or progressed within 1 month from prior advanced/metastatic endocrine breast cancer therapy, 9. non-pregnant and non-lactating. patients of childbearing potential must have a negative serum or urine pregnancy test. 10. adequate breast size for safe ire. male breast cancer patients and female breast cancer patients with breasts too small to allow safe ire are not eligible as the minimal thickness of the breast tissue does not lend itself to ire. note: for patients with breast implants, the treating physician must document that adequate distance exists between the lesion and the implant to ensure that the ablated lesion will not contact or jeopardize the implant. 11. adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures 12. patient must agree to provide tumor tissue from metastatic tissue at baseline. exclusion criteria: 1. patients with multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or evidence of excessive dcis. 2. history of rotational vacuum assisted core biopsies, en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer. 3. prior or planned neoadjuvant chemotherapy for breast cancer. 4. patients with thrombocytopenia and or any other coagulation abnormality
patient preference comparison of azarga versus cosopt in patients with glaucoma

Conditions: Glaucoma

Summary: the purpose of this study is to assess patient preference of azarga® compared to cosopt® after a single drop of each medication is administered to both eyes, in patients with open-angled glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes. * on a stable regimen intraocular pressure (iop) lowering medication within 30 days of screening visit. * iop considered to be safe (in the opinion of the investigator) in both eyes in such a way that should assure clinical stability of vision and the optic nerve throughout the study period. * willing to discontinue use of all other ocular drugs (prescribed and over-the-counter) prior to receiving the screening dose during screening visit and for the course of the study. * other protocol-defined inclusion criteria may apply. exclusion criteria: * known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in this study that is deemed clinical significant in the opinion of the principal investigator. * corneal dystrophies in either eye. * risk of visual field or visual acuity worsening as a consequence of participating in this study, in the investigator's best judgment. * bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker. * history of severe allergic rhinitis. * participation in any other investigational study within 30 days prior to the screening/baseline visit. * other protocol-defined exclusion criteria may apply.

Keywords: primary open-angle glaucoma ocular hypertension pigment dispersion glaucoma
quantifying micro rna levels of colon

Conditions: Colorectal Carcinoma (CRC) Patients

Summary: colorectal cancer (crc) is the third most common cancer and the fourth leading cause of cancer-related death in the world. despite potentially curative surgery and the use of modern adjuvant chemotherapy, up to 40% of crc patients subsequently develop local tumor relapse or metastatic disease. currently, aside from post-operative pathological staging, early follow up of the patients does not include a specific test or any other evaluation that could predict disease recurrence. therefore, exploring and identifying novel biomarkers of crc's following diagnosis of the primary tumor may help us in identifying patients at high risk for recurrence. modifications in signaling pathways and their regulation by micrornas (mirnas) are being evaluated as biomarkers and therapeutic targets for cancer in general and crc in particular. it has been established, although not completely, that mirnas have a role in initiation and progression of crc. modifications of mirnas have been recorded in crc tumors, and the expression patterns of these mirnas could in principle biomark this cancer's phenotype. as mirnas are well documented to regulate critical molecules in signaling pathways, their regulation of tumor relevant pathways may also serve to further sub-classify patients into drug responsive groups. moreover, mirnas may be sampled from peripheral blood and are available as a non-invasive diagnostic method, their application as biomarkers is of special interest. in this study the investigators aim to quantify mirna levels in human colon and rectal tumors, tumor adjacent and normal tissues. by comparing this data from a large cohort of patients, the investigators aim to identify specific, relevant mirnas that may serve as biomarkers to stratify crc patients according to their clinical characteristics such as disease stage, specific treatment, prognosis and disease recurrence.


Eligibility criteria:
inclusion criteria: adult men and women over the age of 18 years who underwent colon resection of any kind are suitable candidates for this study. exclusion criteria: pregnant woman and children (under the age of 18 years) will not be included in this study.

Keywords: crc mirna
efficacy and safety of lomitapide in japanese patients with hofh on concurrent lipid-lowering therapy

Conditions: Familial Hypercholesterolemia - Homozygous

Summary: study to evaluate the efficacy and safety of lomitapide in japanese patients with homozygous familial hypercholesterolemia (hofh) on concurrent lipid-lowering therapy.

this is a phase 3, single-arm, open-label, multicenter clinical trial to evaluate both the efficacy and long-term safety of lomitapide in japanese patients with hofh receiving maximally-tolerated, stable lipid-lowering therapy. this study is comprised of a run-in period, a primary 26-week efficacy phase, and a 30-week safety phase.

Eligibility criteria:
inclusion criteria: 1. japanese male and female patients aged ≥ 18 years of age who are receiving maximally tolerated, stable, lipid-lowering therapy 2. diagnosis of functional hofh 3. body weight ≥ 40 kg and \< 136 kg 4. negative pregnancy test at screening exclusion criteria: 1. uncontrolled hypertension 2. history of chronic renal insufficiency 3. history of biopsy proven cirrhosis or abnormal liver function tests (lfts) at screening 4. any major surgical procedure occurring \< 3 months prior to the screening visit 5. cardiac insufficiency 6. previous organ transplantation 7. history of a non-skin malignancy within the previous 3 years 8. patients who are not able to limit their alcohol intake 9. participation in an investigational drug study within 6 weeks prior to the screening visit 10. known significant gastrointestinal bowel disease 11. nursing mothers 12. serious or unstable medical or psychological conditions 13. requirement for certain prohibited medications known to be potentially hepatotoxic 14. use of strong or moderate inhibitors of cyp3a4 15. use of simvastatin at doses \>10 mg per day 16. documented diagnosis of any liver disease
effects of a combined transcranial magnetic stimulation (tms) and cognitive training in alzheimer patients

Conditions: Alzheimer's Disease

Summary: this study looks at the potential benefits of combining cognitive training (mental exercises) together with transcranial magnetic stimulation (also known as tms) to see if this can make a difference in the condition of people with alzheimer's disease by improving their disease and the cognitive decline that goes along with it.

this study takes place in boston, massachusetts and beth israel deaconess medical center. the treatment portion of the study requires patients to visit the bidmc daily, monday through friday, for 6 weeks. all participants will receive real cognitive training, but half of our participants will receive active tms treatment and half will receive a placebo tms treatment. however, those receiving the placebo treatment will be offered the real treatment upon the completion of the study. this study goes up to approximately 4.5 months. tms is a noninvasive way of stimulating the brain, which is not painful and does not involve any needles or any form of surgery. it acts by delivering a magnetic stimulation to a particular region of your brain and that, coupled with the cognitive training, is what is being looked at in this study. the investigators are examining if this combination of tms and cognitive training will improve your memory function and other mental functions such as language, orientation, and thinking or judgment.

Eligibility criteria:
inclusion criteria: * male or female age 55-90 * diagnosed with mild to moderate ad according to dsm-iv criteria * diagnosis of dementia of the alzheimer's type according to the criteria established by the nincds-adrda * normal or corrected normal ability to see and hear * primary language is english exclusion criteria: * iq below 85 * any major structural abnormalities on mri (eg. infarction, intracerebral malformation) * any symptoms of disease or abnormalities sufficient to cause memory impairment other than ad (eg. normal pressure hydrocephalus, progressive supranuclear palsy) * any functional psychiatric disorder (eg. schizophrenia) * chronic uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (eg. cardiac malformation) * history of seizures, diagnosis of epilepsy * metal implants excluding dental fillings or any of the following medical devices: pacemaker, implanted medication pump, vagal nerve stimulator, deep brain stimulator, tens unit (unless removed completely for this study), cerebral spinal fluid shunt * recent withdrawal from the following drugs: alcohol, barbiturates, benzodiazepines, meprobamate, chloral hydrate

Keywords: alzheimer's disease cognitive training transcranial magnetic stimulation
characterization of antibacterial antibodies in patients with cystic fibrosis

Conditions: Pulmonary Cystic Fibrosis; Neutralizing Antibodies

Summary: most of the cystic fibrosis (cf) patients are or have been pulmonary colonized with bacteria such as pseudomonas aeruginosa or staphylococcus aureus. aim of this study is to detect virulence factor neutralizing antibodies in the sera of the study population followed by b cell repertoire analyses to design b cell-derived neutralizing monoclonal antibodies. the functionality of neutralizing antibodies rests on inhibition of virulence factors by binding of crucial epitopes rather than merely the induction of opsonization. focusing on patients with bacterial colonization/chronic infections or a history of an acute infection in the past, will increase the likelihood for identification of serum with neutralizing activity as in vivo antigen contact is a prerequisite for antibody development and maturation. since virulence factors are essential for infection, dissemination and tissue damage, inhibition of these factors by developed neutralizing antibodies might contribute to a favorable outcome of life-threatening infections.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * ability to give consent * normal vital signs including: * blood pressure systolic value 150 - 100 mmhg, diastolic value \< 90 mmhg * respiratory rate \< 20/min * oxygen saturation \>92% * heart rate 50 - 110/min * body temperature \<38°c exclusion criteria: * cytopenia (leukocytes \< 1.500/µl, thrombocytes \< 50.000/µl, hemoglobin \< 12 g/dl) * heart disease or pulmonary hypertension * body weight \<50 kg (exclusion of blood sampling for b cell isolation) * blood donation, larger blood loss and/or major surgery in the last 8 (male) or 12 (female) weeks * any decline of the general state of health in the last 3 month including weight loss \> 2kg, pulmonal exacerbation or increased impairment of pulmonary function (fev1 \< 50%)